EMA panel backs EU approval of Roche’s Ocrevus for pediatric relapsing MS patients 10+ - RHHBY News | RalliesEMA panel backs EU approval of Roche’s Ocrevus for pediatric relapsing MS patients 10+
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RHHBY• EMA panel recommends EU approval for pediatric relapsing MS
- EMA’s CHMP recommended EU approval of Roche’s Ocrevus IV for relapsing multiple sclerosis in patients aged 10 and older.
- European Commission decision expected soon; FDA cleared the pediatric use in May 2026.
- Phase III OPERETTA 2 showed non-inferior relapse control versus fingolimod; 48% lower relapse risk.
